TriangleNCT00441337 · OUTCOME
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
What was measured
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.
Analysis population: Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
Groups in this outcome
0.3 mg/kg Nivolumab
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1 mg/kg Nivolumab
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
3 mg/kg Nivolumab
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
10 mg/kg Nivolumab
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
| Group | Source count |
|---|---|
| 0.3 mg/kg Nivolumab | 6 |
| 1 mg/kg Nivolumab | 6 |
| 3 mg/kg Nivolumab | 6 |
| 10 mg/kg Nivolumab | 21 |
Reported measurements
Severe AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 4 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 18 | Not reported | Not reported | Not reported | Not reported |
SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 3 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 4 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 9 | Not reported | Not reported | Not reported | Not reported |
SAE through 28 days post study discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 3 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 4 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 11 | Not reported | Not reported | Not reported | Not reported |
Drug-Related AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 5 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 6 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 19 | Not reported | Not reported | Not reported | Not reported |
Death
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 4 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 6 | Not reported | Not reported | Not reported | Not reported |
Discontinuation of Study Drug due to AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 2 | Not reported | Not reported | Not reported | Not reported |
irAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 3 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 2 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 9 | Not reported | Not reported | Not reported | Not reported |
Dose-Limiting Toxicity AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 18
- title
- Severe AE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 9
- title
- SAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- title
- SAE through 28 days post study discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 19
- title
- Drug-Related AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- Discontinuation of Study Drug due to AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- title
- irAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Dose-Limiting Toxicity AE
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.
- groups
- description
- 0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
- id
- OG000
- title
- 0.3 mg/kg Nivolumab
- description
- 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
- id
- OG001
- title
- 1 mg/kg Nivolumab
- description
- 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
- id
- OG002
- title
- 3 mg/kg Nivolumab
- description
- 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
- id
- OG003
- title
- 10 mg/kg Nivolumab
- param Type
- NUMBER
- population Description
- Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.
- reporting Status
- POSTED
- time Frame
- Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation
- title
- Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population
- type
- PRIMARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice