NCT01412957 · OUTCOME
Number of Participants With Adverse Events (AEs)
Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer · Source last updated 2017-03-15
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
- From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
What was measured
The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.
Analysis population: Safety Analysis Set (all randomized participants)
Groups in this outcome
Panitumumab + BSC
Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
BSC Alone
Participants received best supportive care until disease progression, withdrawal of consent, or death.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Panitumumab + BSC | 189 |
|---|
| BSC Alone | 188 |
|---|
Reported measurements
Any adverse event (AE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 184 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 115 | Not reported | Not reported | Not reported | Not reported |
|---|
AE with worst grade of 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
AE with worst grade of 4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
AE with worst grade of 5
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse event (SAE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
AE leading to discontinuation of panitumumab
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | NA | Not reported | Not reported | Not reported | Not applicable for BSC Alone arm |
|---|
Treatment-related adverse event (TRAE)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 166 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related AE with worst grade of 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related AE with worst grade of 4
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related AE with worst grade of 5
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious treatment-related AE
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE leading to discontinuation of panitumumab
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Panitumumab + BSC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| BSC Alone | NA | Not reported | Not reported | Not reported | Not applicable for BSC Alone arm |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 184
- group Id
- OG001
- value
- 115
- title
- Any adverse event (AE)
- categories
- measurements
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 29
- title
- AE with worst grade of 3
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 5
- title
- AE with worst grade of 4
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- title
- AE with worst grade of 5
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 37
- title
- Serious adverse event (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 20
- comment
- Not applicable for BSC Alone arm
- group Id
- OG001
- value
- NA
- title
- AE leading to discontinuation of panitumumab
- categories
- measurements
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 7
- title
- Treatment-related adverse event (TRAE)
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 1
- title
- Treatment-related AE with worst grade of 3
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- title
- Treatment-related AE with worst grade of 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Treatment-related AE with worst grade of 5
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Serious treatment-related AE
- categories
- measurements
- group Id
- OG000
- value
- 1
- comment
- Not applicable for BSC Alone arm
- group Id
- OG001
- value
- NA
- title
- TRAE leading to discontinuation of panitumumab
- denoms
- counts
- group Id
- OG000
- value
- 189
- group Id
- OG001
- value
- 188
- units
- Participants
- description
- The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.
- groups
- description
- Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
- id
- OG000
- title
- Panitumumab + BSC
- description
- Participants received best supportive care until disease progression, withdrawal of consent, or death.
- id
- OG001
- title
- BSC Alone
- param Type
- NUMBER
- population Description
- Safety Analysis Set (all randomized participants)
- reporting Status
- POSTED
- time Frame
- From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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