Comparison · NCT01314105-c88edfbf
Nintedanib 150mg vs Nintedanib 200mg: Dose Limiting Toxicities During Treatment Course 1
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. Nintedanib 150mg vs Nintedanib 200mg: Dose Limiting Toxicities During Treatment Course 1. Trial comparisons, record NCT01314105-c88edfbf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01314105-c88edfbf
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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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.42 | 0.42 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0796 | 12.6 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.048 | 20.8 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Nintedanib 150mg | Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. | 1 | 6 | OG000 |
| Group 2 | Nintedanib 200mg | Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. | 1 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Dose Limiting Toxicities During Treatment Course 1
- Description
Number of patients with dose limiting toxicity (DLT) occurring during treatment course 1~The following AEs were to be reported as DLT events if their occurrence was considered to be drug-related:~Haematological toxicity:~* Any CTCAE grade 4 haematological toxicity~* CTCAE grade 4 neutropenia that was not associated with fever ≥38.5°C, if persisting for \>7 days despite adequate supportive treatment~* CTCAE grade ≥3 neutropenia of any duration if associated with fever ≥38.5°C~* Any CTCAE grade 4 thrombocytopenia~* CTCAE grade ≥3 thrombocytopenia if associated with bleeding of CTCAE grade ≥2~Non-haematological toxicity:~* CTCAE grade ≥3 diarrhoea despite optimal medical management~* CTCAE grade 2 diarrhoea persisting for more than 7 days despite optimal medical management~* CTCAE grade ≥2 vomiting despite optimal medical management~* ALT and/or AST elevation of CTCAE grade ≥3~* ALT and/or AST elevation of \>3x ULN in conjunction with bilirubin increase \>2x ULN
- Time frame
- First 28-day treatment cycle
- Population
MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period
Source ClinicalTrials.gov
Trial
- Title
- BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
- NCT number
- NCT01314105
- Phases
- PHASE1
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms
- Interventions
- BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2014-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01314105?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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