Truqap Adverse Reactions

Overall summary of the safety profile: The safety profile of TRUQAP is based on data from 355 patients who received TRUQAP plus fulvestrant in CAPItello-291.
The most common adverse reactions (reported at a frequency of ≥20%), were diarrhoea (72.4%), rash (40.3%), nausea (34.6%), fatigue (20.8%) and vomiting (20.6%). The most common grade 3 or 4 adverse reactions (reported at frequency ≥2%) were rash (12.4%), diarrhoea (9.3%), hyperglycaemia (2.3%), anaemia (2.0%), and stomatitis (2.0%).
Serious adverse reactions (SARs) were seen in 23 (6.5%) patients receiving TRUQAP plus fulvestrant. Serious adverse reactions reported in ≥1% of patients receiving TRUQAP plus fulvestrant included rash 8 (2.3%), diarrhoea 6 (1.7%), and vomiting 4 (1.1%).
Dose reductions due to adverse reactions were reported in 62 (17.5%) patients. The most common adverse reactions (reported at frequency ≥2%) leading to dose reduction of TRUQAP were diarrhoea (7.9%) and rash (4.5%).
Treatment discontinuation due to adverse reactions occurred in 33 (9.3%) patients. The most common adverse reactions (reported at frequency ≥2%) leading to treatment discontinuation were rash (4.5%), diarrhoea (2.0%), and vomiting (2.0%).
Adverse Drug Reactions: Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 9.)

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Description of selected adverse reaction: Hyperglycaemia: Hyperglycaemia of any grade occurred in 60 (16.9%) patients and grade 3 or 4 occurred in 8 (2.3%) patients receiving TRUQAP. In the study, dose reduction was required in 2 (0.6%) patients and 1 (0.3%) patient discontinued treatment due to hyperglycaemia. In the 60 patients with hyperglycaemia, 28 (46.7%) patients were treated using anti-hyperglycaemic medication (including insulin in 10 (16.7%) patients).
Diarrhoea: Diarrhoea occurred in 257 (72.4%) patients receiving TRUQAP. Grade 3 and/or 4 diarrhoea occurred in 33 (9.3%) patients. Dose reduction was required in 28 (7.9%) patients and 7 (2.0%) patients discontinued TRUQAP due to diarrhoea. In the 257 patients with diarrhoea, anti-diarrheal medication was required in 59% (151/257) of patients to manage diarrhoea symptoms.
Rash: Rash (including erythema, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, and rash pruritic) was reported in 143 (40.3%) patients. Grade 3 and/or 4 occurred in 44 (12.4%) of patients who received capivasertib. Dose reduction was required in 16 (4.5%) patients and 16 (4.5%) patients discontinued TRUQAP due to rash.