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NCT02676778 · ADVERSE EVENTS

Adverse events

Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma · Source last updated 2021-07-15

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 the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PTCL: E7777 9 mcg/kg/Day

Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).

9 / 1717 / 170 / 17
CTCL: E7777 9 mcg/kg/Day

Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).

8 / 1919 / 191 / 19
Other: E7777 9 mcg/kg/Day

Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).

0 / 11 / 10 / 1

Group identifiers: EG000: PTCL: E7777 9 mcg/kg/Day · EG001: CTCL: E7777 9 mcg/kg/Day · EG002: Other: E7777 9 mcg/kg/Day

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Hepatic function abnormal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cytomegalovirus chorioretinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Herpes zoster
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Rhabdomyolysis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Squamous cell carcinoma of skin

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cardiomegaly
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Supraventricular extrasystoles
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    PTCL: E7777 9 mcg/kg/Day
  2. deaths Num Affected
    1
    deaths Num At Risk
    19
    description
    Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    8
    serious Num At Risk
    19
    title
    CTCL: E7777 9 mcg/kg/Day
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Other: E7777 9 mcg/kg/Day
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cardiomegaly
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Supraventricular extrasystoles
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Hepatic function abnormal
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cytomegalovirus chorioretinitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Herpes zoster
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Rhabdomyolysis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Squamous cell carcinoma of skin
time Frame
From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)

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Preserved source evidence · Not medical advice