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NCT03397706 · ADVERSE EVENTS

Adverse events

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies · Source last updated 2025-03-20

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
Up to approximately 2 years
Other-event reporting threshold
5%

Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1b Dose Escalation Cohort 1

VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID

2 / 77 / 74 / 7
Phase 1b Dose Escalation Cohort 2a

VRx-3996: 5 mg BID valganciclovir: 450 mg BID

2 / 55 / 54 / 5
Phase 1b Dose Escalation Cohort 2b

VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID

2 / 44 / 42 / 4
Phase 1b Dose Escalation Cohort 2c

VRx-3996: 10 mg QD valganciclovir: 900 mg QD

1 / 44 / 44 / 4
Phase 1b Dose Escalation Cohort 3

VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD

1 / 55 / 53 / 5
Phase 2 Dose Expansion - Capsule

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

11 / 3022 / 3017 / 30
Phase 2 Dose Expansion - Tablet

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

4 / 96 / 94 / 9

Group identifiers: EG000: Phase 1b Dose Escalation Cohort 1 · EG001: Phase 1b Dose Escalation Cohort 2a · EG002: Phase 1b Dose Escalation Cohort 2b · EG003: Phase 1b Dose Escalation Cohort 2c · EG004: Phase 1b Dose Escalation Cohort 3 · EG005: Phase 2 Dose Expansion - Capsule · EG006: Phase 2 Dose Expansion - Tablet

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
    Infections and infestations
    source Vocabulary
    MeDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Gastrointestinal haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Haematochezia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Oral pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Myelodysplastic syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Transitional cell carcinoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Transitional cell carcinoma metastatic
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Tumour necrosis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Acute kidney injury
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Dyspnoea

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      9
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      9
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Toothache
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Gastroesophageal reflux disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Oral pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      9
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Pyrexia
Complete source fields
description
Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    7
    description
    VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Phase 1b Dose Escalation Cohort 1
  2. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1b Dose Escalation Cohort 2a
  3. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase 1b Dose Escalation Cohort 2b
  4. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Phase 1b Dose Escalation Cohort 2c
  5. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Phase 1b Dose Escalation Cohort 3
  6. deaths Num Affected
    17
    deaths Num At Risk
    30
    description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    EG005
    other Num Affected
    22
    other Num At Risk
    30
    serious Num Affected
    11
    serious Num At Risk
    30
    title
    Phase 2 Dose Expansion - Capsule
  7. deaths Num Affected
    4
    deaths Num At Risk
    9
    description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Phase 2 Dose Expansion - Tablet
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Thrombocytopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      9
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      9
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Stomatitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Dysphagia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Toothache
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Gastroesophageal reflux disease
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Oral pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      9
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      9
    term
    Pyrexia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Gastrointestinal haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Haematochezia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Oral pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Myelodysplastic syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Transitional cell carcinoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Transitional cell carcinoma metastatic
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Tumour necrosis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      9
    term
    Acute kidney injury
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      30
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      9
    term
    Dyspnoea
time Frame
Up to approximately 2 years

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Preserved source evidence · Not medical advice