The table shows up to 24-week (short-term) data regardless of glycaemic rescue.

1. See corresponding subsection in SmPC for additional information.
2. Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
3. Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
4. Volume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
5. See section 4.4 of SmPC for more details.
6. Adverse reaction was identified through postmarketing surveillance. Rash includes the following preferred terms, listed in order of frequency in clinical trials: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous. In active- and placebo-controlled clinical trials (Forxiga, N=5,936, all control, N=3,403), the frequency of rash was similar for Forxiga (1.4%) and all control (1.4%), respectively.
7. Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
8. Mean changes from baseline in haematocrit were 2.30% for Forxiga 10 mg versus -0.33% for placebo. Haematocrit values >55% were reported in 1.3% of the subjects treated with Forxiga 10 mg versus 0.4% of placebo subjects.
9. Mean percent change from baseline for Forxiga 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
10. Frequency of adverse reaction was identified from the full study population in 2 placebo-controlled studies in subjects with type 1 diabetes mellitus.
11. Reported in the cardiovascular outcomes study in patients with type 2 diabetes. Frequency is based on annual rate.
12. ^* Reported in ≥2% of subjects and ≥1% more and at least 3 more subjects treated with Forxiga 10 mg compared to placebo.
13. ^** Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥0.2% of subjects and ≥0.1% more and at least 3 more subjects treated with Forxiga 10 mg compared to placebo.

LDL, low-density lipoprotein; HDL, high-density lipoprotein; SU, sufonylurea.