Trial · NCT01724866
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Severe Neutropenia (DSN) in Cycle 1 | Cycle 1 (each cycle was 21 days) | DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 1. |
| Secondary | Duration of DSN in Cycle 2 | Cycle 2 (each cycle was 21 days) | DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 2. |
| Secondary | Duration of DSN in Cycle 3 | Cycle 3 (each cycle was 21 days) | DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 3. |
| Secondary | Duration of DSN in Cycle 4 | Cycle 4 (each cycle was 21 days) | DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 4. |
| Secondary | Time to ANC Recovery in Cycle 1 | Cycle 1 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 1. |
| Secondary | Time to ANC Recovery in Cycle 2 | Cycle 2 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 2. |
| Secondary | Time to ANC Recovery in Cycle 3 | Cycle 3 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 3. |
| Secondary | Time to ANC Recovery in Cycle 4 | Cycle 4 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 4. |
| Secondary | Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1 | Cycle 1 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1. |
| Secondary | Absolute ANC Nadir Overtime in Cycle 2 | Cycle 2 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2. |
| Secondary | Absolute ANC Nadir Overtime in Cycle 3 | Cycle 3 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3. |
| Secondary | Absolute ANC Nadir Overtime in Cycle 4 | Cycle 4 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4. |
| Secondary | Depth of ANC Nadir in Cycle 1 | Cycle 1 (each cycle was 21 days) | Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1. |
| Secondary | Depth of ANC Nadir in Cycle 2 | Cycle 2 (each cycle was 21 days) | Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2. |
| Secondary | Depth of ANC Nadir in Cycle 3 | Cycle 3 (each cycle was 21 days) | Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 3. |
| Secondary | Depth of ANC Nadir in Cycle 4 | Cycle 4 (each cycle was 21 days) | Depth of ANC nadir was defined as the lowest Median ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 4. |
| Secondary | Time to ANC Nadir in Cycle 1 | Cycle 1 (each cycle was 21 days) | Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. |
| Secondary | Time to ANC Nadir in Cycle 2 | Cycle 2 (each cycle was 21 days) | Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. |
| Secondary | Time to ANC Nadir in Cycle 3 | Cycle 3 (each cycle was 21 days) | Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. |
| Secondary | Time to ANC Nadir in Cycle 4 | Cycle 4 (each cycle was 21 days) | Time to ANC nadir was defined as the time from chemotherapy administration until the occurrence of the ANC nadir. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01724866/registered