Comparison · NCT03267940-9c523221
Run-in Portion: PEGCISGEM vs Run-in Portion: PEGCISGEMATEZO: Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Run-in Portion: PEGCISGEM vs Run-in Portion: PEGCISGEMATEZO: Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication. Trial comparisons, record NCT03267940-9c523221. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03267940-9c523221
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.667 | 0.354 | 0.879 | wilson | |
| Risk in group 2 | 0.778 | 0.453 | 0.937 | wilson | |
| Risk difference, group 1 minus group 2 | -0.111 | -0.462 | 0.277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.857 | 0.48 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 0.571 | 0.0703 | 4.64 | log | |
| Number needed to treat, for one fewer participant with the outcome on Run-in Portion: PEGCISGEM than on Run-in Portion: PEGCISGEMATEZO | 9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Run-in Portion: PEGCISGEM | Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days) | 6 | 9 | OG000 |
| Group 2 | Run-in Portion: PEGCISGEMATEZO | Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days) | 7 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
- Description
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
- Time frame
- From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
- Population
- Safety population included all participants who received any study medication.
Source ClinicalTrials.gov
Trial
- Title
Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
- NCT number
- NCT03267940
- Phases
- PHASE1
- Conditions
- Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma
- Interventions
- PEGPH20, CIS, GEM, Atezolizumab
- Lead sponsor
- Halozyme Therapeutics
- Results first posted
- 2020-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03267940?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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