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NCT02684006 · ADVERSE EVENTS

Adverse events

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. For SAEs and non-SAEs safety analysis set was used. For All-cause mortality, FAS was used.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days.

231 / 434429 / 434284 / 442
Sunitinib

Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.

166 / 439433 / 439296 / 444

Group identifiers: EG000: Avelumab + Axitinib · EG001: Sunitinib

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      439
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Immune thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      439
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Acute coronary syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Arteriosclerosis coronary artery
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Atrial fibrillation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      439
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      439
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      439
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      439
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      439
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      439
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      439
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      439
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      303
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      228
      num At Risk
      439
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      439
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      439
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      439
    term
    Gastrooesophageal reflux disease
Complete source fields
description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. For SAEs and non-SAEs safety analysis set was used. For All-cause mortality, FAS was used.
event Groups
  1. deaths Num Affected
    284
    deaths Num At Risk
    442
    description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days.
    id
    EG000
    other Num Affected
    429
    other Num At Risk
    434
    serious Num Affected
    231
    serious Num At Risk
    434
    title
    Avelumab + Axitinib
  2. deaths Num Affected
    296
    deaths Num At Risk
    444
    description
    Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
    id
    EG001
    other Num Affected
    433
    other Num At Risk
    439
    serious Num Affected
    166
    serious Num At Risk
    439
    title
    Sunitinib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      439
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      439
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      439
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      439
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      439
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      439
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      439
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      439
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      303
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      228
      num At Risk
      439
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      439
    term
    Dry mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      439
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      439
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      439
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Immune thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Leukocytosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      439
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Acute coronary syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      439
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Arteriosclerosis coronary artery
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      434
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      439
    term
    Atrial fibrillation
time Frame
From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)

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